GUEST COLUMNISTS

• Suffering High Protein Sieving Losses? It Might Be The Buffer

  New research shows that a common buffer used during diafiltration and ultrafiltration was at the heart of sieving losses, and using an alternative dramatically improved retention.

• Cell & Gene Therapy Manufacturing: Considerations For Early-Stage Companies

  Key considerations for early-stage cell and gene therapy companies include whether to develop and manufacture internally vs. externally, locally vs. not, and how to choose a CDMO.

• Developing ADCs? Here's A Refresher On HPAPI Occupational Health Risk Mitigation

  API payloads used in antibody-drug conjugates are some of the most potent substances in biopharma, so it's important to protect workers who handle them.

• Building Frameworks To Support Complex Therapy Manufacturing

  To make its clinical product, CLBR001+SWI019, the Calibr-Skaggs Institute for Innovative Medicines relies on a complex network of contractors from around the globe.

• Audit Readiness For Cell & Gene Therapy Companies

  Cell & gene therapy companies are required by regulation to qualify sites performing all the steps and methods as part of their manufacturing processes. 

• New Regulatory Survey Findings: Biotech Global Market Access Challenges And Learnings

  To understand biotech companies’ evolving geographic strategies and perceptions, Arriello recently commissioned a transatlantic survey among regulatory, safety, and quality directors at small/medium biotechs, with respondents in Ireland and North America.

• Addressing Blind Spots In Assuring Therapeutic Equivalence

  The new FDA commissioner-designee's focus offers a timely opportunity to expose root causes to distinguish between "special" and "common" causes of deviation and variability in public health and regulatory oversight.

• Hear Me Out — Cell Therapy GMP Starts With The Donor

  Regulators also have indicated they expect allogeneic cell therapy donors to meet more rigid eligibility requirements and undergo screening.